e-NOBORI Observational Registry of Nobori DES

This study is currently recruiting participants.
Verified December 2012 by Terumo Europe N.V.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01261273
First received: December 14, 2010
Last updated: December 6, 2012
Last verified: December 2012

December 14, 2010
December 6, 2012
August 2010
December 2013   (final data collection date for primary outcome measure)
FREEDOM OF TARGET LESION FAILURE [ Time Frame: 1 YEAR ] [ Designated as safety issue: Yes ]
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
Same as current
Complete list of historical versions of study NCT01261273 on ClinicalTrials.gov Archive Site
  • Procedural success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Device success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Acute/subacute stent thrombosis [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    (definite/probable according to ARC definitions)
  • Peri-procedural myocardial infarction [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)
  • Major vascular and bleeding complications [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
    NOT CABG RELATED
  • Cardiac death/ Myocardial Infarction [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Clinically driven target lesion revascularization (TLR) [ Time Frame: 1 & 2 YEARS ] [ Designated as safety issue: Yes ]
    re-PCI or CABG involving target lesion
  • Stent thrombosis [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    (definite/probable; ARC definition)
  • Clinically driven target vessel revascularization (TVR) [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    PCI AND CABG
  • Target Lesion Failure (TLF) [ Time Frame: 1 MONTH AND 2 YEARS ] [ Designated as safety issue: Yes ]
    Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization
  • Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR [ Time Frame: 1 MONTH, 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and MI [ Time Frame: 1 MONTH, 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and post-procedural MI [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions
  • Primary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions
  • Secondary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions
  • Duration of dual antiplatelet therapy [ Time Frame: UP TO 2 YEARS ] [ Designated as safety issue: No ]
  • Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT [ Time Frame: UP TO 2 YEARS ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Lesion Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Vessel Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
e-NOBORI Observational Registry of Nobori DES
Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.

Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.

Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

  • Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
  • Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.
  • Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year
  • Clinical Site Locations:

Up to 200 centres across Europe, Asia and Central and South America

-Patient Population : ~8000 eligible patients suitable for treatment with the Nobori® DES will be entered in the e-NOBORI registry

Eligibility Criteria

  • Patient is more or equal 18 years old;
  • Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes);
  • Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists.

NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all consecutive patients complying with study eligibility criteria. It is also desirable to have at least two cardiologists as investigators in each centre.

According to pre-specified criteria, patients will be automatically allocated to one or more sub-studies as following:

  • NOBORI Acute Coronary Syndrome
  • NOBORI Stable angina
  • NOBORI Female
  • NOBORI Bifurcation
  • NOBORI Diabetes

    • Insulin Dependent Diabetes Mellitus (IDDM)
    • Non-Insulin Dependent Diabetes Mellitus (NIDDM)
  • NOBORI Small Vessels (less or equal 2.75mm)
  • NOBORI Long Lesions (more or equal 20mm)
  • NOBORI Renal Insufficiency (> 2.0 mg/dL - 176 µmol/mL)
  • NOBORI Elderly (more or equal 80 years of age)
  • NOBORI Restenosis
  • NOBORI Multivessel Treatment
  • NOBORI Complex Lesions

In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas.

Medication Pre-Procedure: According to hospital routine practice Post-Procedure: Mandatory antiplatelet treatment, according to hospital routine practice (minimum 6 months DAT)

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients suitable for PCI intervention

Percutaneous Coronary Intervention
Not Provided
  • Stable angina
  • Acute Coronary Syndrome
  • Female
  • Bifurcation
  • Insulin Dependent Diabetes Mellitus
  • Non-Insulin Dependent Diabetes Mellitus
  • Small Vessels
    vessels smaller or equal to 2.75mm
  • NOBORI Long Lesions
    Lesions longer or equal to 20mm
  • Renal Insufficiency
  • Elderly
    Patients more or equal 80 years old
  • Restenosis
  • Multivessel Treatment
  • Complex Lesions
  • Overall

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8000
March 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is more or equal 18 years old;
  • Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes);
  • Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists.

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact: Dragica Paunovic, Dr dragica.paunovic@terumo-europe.com
Bangladesh,   Belarus,   Belgium,   Brazil,   Bulgaria,   Chile,   Czech Republic,   Estonia,   Georgia,   Germany,   Hungary,   Israel,   Latvia,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Sweden,   Ukraine,   United Kingdom
 
NCT01261273
T113E2
Yes
Terumo Europe N.V.
Terumo Europe N.V.
Not Provided
Study Chair: Dragica Paunovic, Dr. Terumo Europe
Terumo Europe N.V.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP